Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
1989-11-17 to 1989-12-24
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read-across from a guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1981
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Induction: 100 %
Challenge: 100 %
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Induction: 100 %
Challenge: 100 %
No. of animals per dose:
Total of 34 animals
4 – preliminary study
20 – main study treatment
10 – main study control
Details on study design:
PRELIMINARY STUDY
Preliminary (for induction): 25 ‐ 50 ‐ 75 ‐ 100%
Topical application 0.5 ml of test material, 6h occlusive dermal exposure, grading at 24 and 48h

Dose‐finding (for challenge): 75 ‐ 100%
Topical application 0.5 ml of test material, 6h occlusive dermal exposure, grading at 24 and 48h


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6-hours
- Test groups: undiluted as supplied
- Site: left flank
- Duration: days 7 and 14
- Concentrations: four different
- Topical application 0.5 g/absorbent lint (4‐6 cm2) of test material (white waxy solid – gently warmed) for 6h under fully occluded conditions, three times at intervals of one week. Skin grading 24h following patch removal at each induction

B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: on day 28 (14 d after beginning of last induction)
- Test groups: undiluted as supplied
- Site: right flank
- Concentrations: two different
- Application of the challenge patch on shaved skin for 6h; skin evaluations 24 and 48h after patch removal


GRADING SYSTEM USED
Dermal reactions graded for erythema and edema by blind reading according to grading scale:
No reaction: 0
Scattered mild redness: 1
Moderate and diffuse redness: 2
Intense redness and swelling: 3
Positive control substance(s):
yes
Remarks:
2,4-Dinitrochlorobenzene (DNCB)

Results and discussion

Positive control results:
The known contact sensitiser, 2,4 -Dinitrochlorobenzene produced a 15/19 sensitisation rate. This was considered to be a satisfactory sensitisation response for this material under the conditions of the test.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
undiluted as supplied
No. with + reactions:
0
Total no. in group:
19
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: undiluted as supplied. No with. + reactions: 0.0. Total no. in groups: 19.0.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
undiluted as supplied
No. with + reactions:
0
Total no. in group:
19
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: undiluted as supplied. No with. + reactions: 0.0. Total no. in groups: 19.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
undiluted as supplied
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: undiluted as supplied. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
undiluted as supplied
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: undiluted as supplied. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

PRELIMINARY STUDY

Result preliminary (for induction): 100% chosen for induction

Result dose‐finding (for challenge): 100% chosen for challenge

MAIN STUDY

No skin responses observed in any of the test or control animals. One animal (No. 1) was found dead at day 14.

POSITIVE CONTROL SUBSTANCE

The known contact sensitiser, 2,4 -Dinitrochlorobenzene produced a 15/19 sensitisation rate. This was considered to be a satisfactory sensitisation response for this material under the conditions of the test.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The test substance "fully saturated TEA-Esterquat" is not a dermal sensitizer in this study.
Executive summary:

In a dermal sensitization study with the "fully saturated TEA-Esterquat", undiluted test substance young adult female Dunkin-Hartley guinea pigs were tested using the method of Bühler according to OECD guideline 406. Positive control material was 2,4-Dinitrochlorobenzene.

Dermal induction was performed with undiluted test substance. None of the animals of the test or control group showed any positive skin reactions after challenge treatment with the undiluted test substance. The sensitisation rate at 24 h and at 48 h was 0 %.

In this study the test substance, “fully saturated TEA-Esterquat”, is considered to be a non-sensitizer.